Sickle Cell DiseaseNCT04917783
Health Literacy - Neurocognitive Screening in Pediatric SCD
A study testing Passport Card and No Passport card in people with Sickle Cell Disease, run by Medical College of Wisconsin at 2 sites in United States.
Trial summary
The purpose of this study is to determine feasibility and potential benefits of providing a passport card with a summary of neurocognitive feedback results to families of patients with sickle cell disease. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Passport Card and No Passport card
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Sep 2019to 8 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants will include English-speaking patients between the ages of 6 and 17 with pediatric sickle cell disease and their caregivers (46 patient-caregiver dyads).
Who cannot join
- Patients will be excluded from participation if they have a history of significant neurological injury or impairment negating the benefit of a neurocognitive screening
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Wisconsin
Milwaukee, Wisconsin, 53201
Medical College of Wisconsin
Milwaukee, Wisconsin, 53266
About this study
Official title: Health Literacy: A Randomized Controlled Trial to Investigate a Novel Feedback Tool for Neurocognitive Screening in Pediatric Sickle Cell Disease
The purpose of this study is to determine feasibility and potential benefits of providing a passport card with a summary of neurocognitive feedback results to families of patients with sickle cell disease. Given recent literature suggesting the need to be conscious of health literacy in populations with low socioeconomic status, this project is intended to provide a more health-literate appropriate format of neurocognitive evaluation feedback in the context of a routine screening program offered as a standard of care in the CHW pediatric sickle cell disease clinic. The specific aims is (1) to evaluate differences in caregiver understanding of neurocognitive report findings when provided with a health-literate passport card compared to control group and (2) to evaluate differences in follow-through on neurocognitive report recommendations when provided with a health-literate passport card compared to control group.
Read the detailed description
Pediatric sickle cell disease (SCD) is a blood disorder affecting approximately 70,000 to 100,000 individuals in the United States. Approximately 80% of individuals affected by SCD are African American, with approximately one out of every 346 individuals in this racial group diagnosed. Sickle cell disease is associated with broad neurocognitive impairment. Compared to their healthy peers, children with SCD demonstrate deficits in intellectual functioning, verbal abilities, visual-motor, and visual-spatial skills, short-term memory, executive functioning, attention and focus, and processing speed.
Neurocognitive deficits can result from primary disease-related factors including chronic anemia, hypoxemia, or cerebrovascular ischemia; as well as secondary factors such as missed school and a higher prevalence of socio-economic disadvantages in African American children. While direct neurological impact appears to be associated with neurocognitive performance, it was found that even children with no MRI abnormality evidence lower intellectual functioning skills than healthy controls, suggesting that "biological, socioeconomic, and environmental" factors are all implicated in neurocognitive impairment.
Because of these deficits, children with SCD are more likely to be retained in school relative to other African American students at the local and national levels. In addition, poorer cognitive and academic performance is associated with a decrease in patient-reported quality of life and general psychosocial functioning. In turn, greater levels of stress and negative mood are correlated with higher levels of reported pain, greater health care utilization, and reduced physical activity. It appears that sickle cell disease not only contributes to poorer neurocognitive and social-emotional well-being, but that declines in these domains can further exacerbate sickle cell disease symptoms.
Because of the deficits in neurocognitive functioning of children with SCD, routine screening is recommended to assess for cognitive deficits and provide appropriate recommendations. Unfortunately, prior research in SCD suggests limited follow-up on referrals and recommendations. For example, it was found that 25% of children with SCD evaluated by a neuropsychologist met the criteria for ADHD, but only 21% of the children subsequently diagnosed with ADHD were prescribed medication. In addition, it was found that children with SCD were not universally receiving appropriate school accommodations and interventions based on their cognitive deficits, despite the recommendation that school-based services be implemented immediately for children with SCD.
The disconnect between the cognitive, emotional/behavioral, and academic deficits are typically seen in children with SCD and the actual support received may be due in part to low health literacy and the provision of complex reports following testing. Health literacy has been found to be low in adolescents and adults with sickle cell disease. Another study found that caregivers of children with SCD had a low level of baseline disease-related knowledge but that this knowledge did improve with in-person education; however, this knowledge appeared to decline over time. Unfortunately, materials developed to improve knowledge often do not fit criteria for broad population health literacy. One study found that patient education materials developed for patients with sickle cell disease and their families ranged from an 8th to 12th grade reading level, with limited potential to translate written recommendations into concrete actions.
Broadly, research suggests the need for a change within the historical format of neurocognitive evaluation reports. It is noted as a need to make written reports provided to families more efficient, readable, and effective. Providing appropriate feedback to families appears essential, as it can improve health-related quality of life, coping, and understanding. An informal calculation of the current reports provided to families in our clinic's neurocognitive screening program suggested that reports averaged a reading level grade of 12.3 and approximately 17,500 words, standing in stark contrast to health literacy recommendations. Addressing the poor health literacy of neurocognitive feedback evaluations has two primary problems. First, these reports often have multiple intended audiences beyond caregivers, including teachers, school psychologists, physicians, and other professionals working with the child. These individuals may benefit from more detailed and technical information. In addition, some of the wording used in neurocognitive reports is standardized and can lose meaning or be technically incorrect if simplified. Thus, it appears essential to evaluate whether the addition of a health-literate passport card will help address disparities in understanding of results and patient/family follow-through after receiving a neurocognitive evaluation.
This study is innovative in being the first to our knowledge to investigate the use of a tangible tool, namely a "passport" style printed card, to address health literacy concerns by conveying the most important findings and recommended follow-up after completion of a neurocognitive evaluation. In other contexts, healthcare passport cards have demonstrated the ability to improve communication among families and other providers, make information and recommendations portable, and enhance continuity of care. However, the use of passport cards has not been evaluated as a potential solution to the problem plaguing neuropsychological evaluations, namely the provision of overly lengthy and complex reports following testing.
- Conditions
- Sickle Cell Disease
- Being tested
- Passport Card, No Passport card
- Keywords
- Health Literacy, Neuropsychology, Hematology, academic achievement
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passport CardBehavioural
After receiving neurocognitive testing, caregivers in the health-literacy group will be provided with a color-coded "passport" (a two-sided wallet-sized card) highlighting key findings and recommendations along with their written report. Then, approximately 7 - 14 weeks after testing, caregivers will complete a brief questionnaire in person during their follow-up clinic visit or via phone if necessary. The person completing the parent/caregiver/guardian report must have been present for the evaluation and feedback session and must be the parent/caregiver/guardian who received the feedback passport card and evaluation report.
No Passport cardBehavioural
After receiving neurocognitive testing and verbal feedback from the psychologist, approximately 7 - 14 weeks after testing, caregivers will complete a brief questionnaire in person during their follow-up clinic visit or via phone if necessary. The person completing the parent/caregiver/guardian report must have been present for the evaluation and feedback session and must be the parent/caregiver/guardian who received the feedback and evaluation report, but not the passport card.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Caregivers in the standard of care-arm will receive immediate verbal feedback by a psychologist on their neurocognitive testing results, recommendations, and guidance for implementing recommendations (e.g., sending a 504 Plan request to the school). This report will contain information regarding background, test results, a summary and impressions, and bullet-pointed recommendations. Receives: Behavioral: No Passport card |
| Health Literacy | Experimental | Participants randomized to the experimental health-literacy group will be provided with a color-coded "passport" (a two-sided wallet-sized card) highlighting key findings and recommendations of their neurocognitive testing results along with the full written report. The domains listed as either satisfactory or needing help listed on the passport card will directly correspond to those listed on the full report. Receives: Behavioral: Passport Card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Understanding
Evaluate differences in caregiver understanding of neurocognitive report findings when provided with a health-literate passport card compared to the control group through the semi-structured interview.
Measured: 7-14 weeks post evaluation
Caregiver Follow-through
Evaluate differences in follow-through on neurocognitive report recommendations when provided with a health-literate passport card compared to the control group through the semi-structured interview.
Measured: 7-14 weeks post evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start25 Sep 2019
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Karst, Medical College of Wisconsin
- Investigators
- Jeffrey Karst, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917783
- Sponsor's protocol ID
- 1345169
- Status last verified
- Apr 2022
- First submitted
- 2 Jun 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As of right now we are not going to share study documents or data.
Publications
Acquazzino MA, Miller M, Myrvik M, Newby R, Scott JP. Attention Deficit Hyperactivity Disorder in Children With Sickle Cell Disease Referred for an Evaluation. J Pediatr Hematol Oncol. 2017 Jul;39(5):350-354. doi: 10.1097/MPH.0000000000000847.
PubMed 28538513Anie KA. Psychological complications in sickle cell disease. Br J Haematol. 2005 Jun;129(6):723-9. doi: 10.1111/j.1365-2141.2005.05500.x.
PubMed 15952997Baum KT, von Thomsen C, Elam M, Murphy C, Gerstle M, Austin CA, Beebe DW. Communication is key: the utility of a revised neuropsychological report format. Clin Neuropsychol. 2018 Apr;32(3):345-367. doi: 10.1080/13854046.2017.1413208. Epub 2017 Dec 15.
PubMed 29243544Berkelhammer LD, Williamson AL, Sanford SD, Dirksen CL, Sharp WG, Margulies AS, Prengler RA. Neurocognitive sequelae of pediatric sickle cell disease: a review of the literature. Child Neuropsychol. 2007 Mar;13(2):120-31. doi: 10.1080/09297040600800956.
PubMed 17364569Brandow AM, Zappia KJ, Stucky CL. Sickle cell disease: a natural model of acute and chronic pain. Pain. 2017 Apr;158 Suppl 1(Suppl 1):S79-S84. doi: 10.1097/j.pain.0000000000000824. No abstract available.
PubMed 28221286Caldwell EP, Carter P, Becker H, Mackert M. The Use of the Newest Vital Sign Health Literacy Instrument in Adolescents With Sickle Cell Disease. J Pediatr Oncol Nurs. 2018 Sep/Oct;35(5):361-367. doi: 10.1177/1043454218767875. Epub 2018 Apr 16.
PubMed 29658377Creary S, Adan I, Stanek J, O'Brien SH, Chisolm DJ, Jeffries T, Zajo K, Varga E. Sickle cell trait knowledge and health literacy in caregivers who receive in-person sickle cell trait education. Mol Genet Genomic Med. 2017 Nov;5(6):692-699. doi: 10.1002/mgg3.327. Epub 2017 Aug 23.
PubMed 29178654Daly, B. P., Kral, M. C., & Brown, R. T. (2008). Cognitive and academic problems associated with childhood cancers and sickle cell disease. School Psychology Quarterly, 23(2), 230-242. https://doi.org/10.1037/1045-3830.23.2.230
Davis DW, Jones VF, Logsdon MC, Ryan L, Wilkerson-McMahon M. Health promotion in pediatric primary care: importance of health literacy and communication practices. Clin Pediatr (Phila). 2013 Dec;52(12):1127-34. doi: 10.1177/0009922813506607. Epub 2013 Oct 21.
PubMed 24146229Gil KM, Carson JW, Porter LS, Ready J, Valrie C, Redding-Lallinger R, Daeschner C. Daily stress and mood and their association with pain, health-care use, and school activity in adolescents with sickle cell disease. J Pediatr Psychol. 2003 Jul-Aug;28(5):363-73. doi: 10.1093/jpepsy/jsg026.
PubMed 12808013Hardy SJ, Bills SE, Wise SM, Hardy KK. Cognitive Abilities Moderate the Effect of Disease Severity on Health-Related Quality of Life in Pediatric Sickle Cell Disease. J Pediatr Psychol. 2018 Sep 1;43(8):882-894. doi: 10.1093/jpepsy/jsy019.
PubMed 29659914Haywood C Jr, Lanzkron S, Ratanawongsa N, Bediako SM, Lattimer L, Powe NR, Beach MC. The association of provider communication with trust among adults with sickle cell disease. J Gen Intern Med. 2010 Jun;25(6):543-8. doi: 10.1007/s11606-009-1247-7. Epub 2010 Mar 3.
PubMed 20195785Kawadler JM, Clayden JD, Clark CA, Kirkham FJ. Intelligence quotient in paediatric sickle cell disease: a systematic review and meta-analysis. Dev Med Child Neurol. 2016 Jul;58(7):672-9. doi: 10.1111/dmcn.13113. Epub 2016 Mar 31.
PubMed 27038278Kral MC, Brown RT, Hynd GW. Neuropsychological aspects of pediatric sickle cell disease. Neuropsychol Rev. 2001 Dec;11(4):179-96. doi: 10.1023/a:1012901124088.
PubMed 11883668McCleary-Jones V. Health literacy and its association with diabetes knowledge, self-efficacy and disease self-management among African Americans with diabetes mellitus. ABNF J. 2011 Spring;22(2):25-32.
PubMed 21675666
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy: A Randomized Controlled Trial to Investigate a Novel Feedback Tool for Neurocognitive Screening in Pediatric Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT04917783
- Acronym / sponsor ID
- 1345169
- Conditions
- Sickle Cell Disease
- Keywords
- Health Literacy, Neuropsychology, Hematology, academic achievement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine feasibility and potential benefits of providing a passport card with a summary of neurocognitive feedback results to families of patients with sickle cell disease. Given recent literature suggesting the need to be conscious of health literacy in populations with low socioeconomic status, this project is intended to provide a more health-literate appropriate format of neurocognitive evaluation feedback in the context of a routine screening program offered as a standard of care in the CHW pediatric sickle cell disease clinic. The specific aims is (1) to evaluate differences in caregiver understanding of neurocognitive report findings when provided with a health-literate passport card compared to control group and (2) to evaluate differences in follow-through on neurocognitive report recommendations when provided with a health-literate passport card compared to control group.
Detailed description
Pediatric sickle cell disease (SCD) is a blood disorder affecting approximately 70,000 to 100,000 individuals in the United States. Approximately 80% of individuals affected by SCD are African American, with approximately one out of every 346 individuals in this racial group diagnosed. Sickle cell disease is associated with broad neurocognitive impairment. Compared to their healthy peers, children with SCD demonstrate deficits in intellectual functioning, verbal abilities, visual-motor, and visual-spatial skills, short-term memory, executive functioning, attention and focus, and processing speed.
Neurocognitive deficits can result from primary disease-related factors including chronic anemia, hypoxemia, or cerebrovascular ischemia; as well as secondary factors such as missed school and a higher prevalence of socio-economic disadvantages in African American children. While direct neurological impact appears to be associated with neurocognitive performance, it was found that even children with no MRI abnormality evidence lower intellectual functioning skills than healthy controls, suggesting that "biological, socioeconomic, and environmental" factors are all implicated in neurocognitive impairment.
Because of these deficits, children with SCD are more likely to be retained in school relative to other African American students at the local and national levels. In addition, poorer cognitive and academic performance is associated with a decrease in patient-reported quality of life and general psychosocial functioning. In turn, greater levels of stress and negative mood are correlated with higher levels of reported pain, greater health care utilization, and reduced physical activity. It appears that sickle cell disease not only contributes to poorer neurocognitive and social-emotional well-being, but that declines in these domains can further exacerbate sickle cell disease symptoms.
Because of the deficits in neurocognitive functioning of children with SCD, routine screening is recommended to assess for cognitive deficits and provide appropriate recommendations. Unfortunately, prior research in SCD suggests limited follow-up on referrals and recommendations. For example, it was found that 25% of children with SCD evaluated by a neuropsychologist met the criteria for ADHD, but only 21% of the children subsequently diagnosed with ADHD were prescribed medication. In addition, it was found that children with SCD were not universally receiving appropriate school accommodations and interventions based on their cognitive deficits, despite the recommendation that school-based services be implemented immediately for children with SCD.
The disconnect between the cognitive, emotional/behavioral, and academic deficits are typically seen in children with SCD and the actual support received may be due in part to low health literacy and the provision of complex reports following testing. Health literacy has been found to be low in adolescents and adults with sickle cell disease. Another study found that caregivers of children with SCD had a low level of baseline disease-related knowledge but that this knowledge did improve with in-person education; however, this knowledge appeared to decline over time. Unfortunately, materials developed to improve knowledge often do not fit criteria for broad population health literacy. One study found that patient education materials developed for patients with sickle cell disease and their families ranged from an 8th to 12th grade reading level, with limited potential to translate written recommendations into concrete actions.
Broadly, research suggests the need for a change within the historical format of neurocognitive evaluation reports. It is noted as a need to make written reports provided to families more efficient, readable, and effective. Providing appropriate feedback to families appears essential, as it can improve health-related quality of life, coping, and understanding. An informal calculation of the current reports provided to families in our clinic's neurocognitive screening program suggested that reports averaged a reading level grade of 12.3 and approximately 17,500 words, standing in stark contrast to health literacy recommendations. Addressing the poor health literacy of neurocognitive feedback evaluations has two primary problems. First, these reports often have multiple intended audiences beyond caregivers, including teachers, school psychologists, physicians, and other professionals working with the child. These individuals may benefit from more detailed and technical information. In addition, some of the wording used in neurocognitive reports is standardized and can lose meaning or be technically incorrect if simplified. Thus, it appears essential to evaluate whether the addition of a health-literate passport card will help address disparities in understanding of results and patient/family follow-through after receiving a neurocognitive evaluation.
This study is innovative in being the first to our knowledge to investigate the use of a tangible tool, namely a "passport" style printed card, to address health literacy concerns by conveying the most important findings and recommended follow-up after completion of a neurocognitive evaluation. In other contexts, healthcare passport cards have demonstrated the ability to improve communication among families and other providers, make information and recommendations portable, and enhance continuity of care. However, the use of passport cards has not been evaluated as a potential solution to the problem plaguing neuropsychological evaluations, namely the provision of overly lengthy and complex reports following testing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Behavioral: No Passport cardCaregivers in the standard of care-arm will receive immediate verbal feedback by a psychologist on their neurocognitive testing results, recommendations, and guidance for implementing recommendations (e.g., sending a 504 Plan request to the school). This report will contain information regarding background, test results, a summary and impressions, and bullet-pointed recommendations. |
| Health Literacy | Experimental | Behavioral: Passport CardParticipants randomized to the experimental health-literacy group will be provided with a color-coded "passport" (a two-sided wallet-sized card) highlighting key findings and recommendations of their neurocognitive testing results along with the full written report. The domains listed as either satisfactory or needing help listed on the passport card will directly correspond to those listed on the full report. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants will include English-speaking patients between the ages of 6 and 17 with pediatric sickle cell disease and their caregivers (46 patient-caregiver dyads).
Key exclusion criteria (1 listed)
- Patients will be excluded from participation if they have a history of significant neurological injury or impairment negating the benefit of a neurocognitive screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passport CardAfter receiving neurocognitive testing, caregivers in the health-literacy group will be provided with a color-coded "passport" (a two-sided wallet-sized card) highlighting key findings and recommendations along with their written report. Then, approximately 7 - 14 weeks after testing, caregivers will complete a brief questionnaire in person during their follow-up clinic visit or via phone if necessary. The person completing the parent/caregiver/guardian report must have been present for the evaluation and feedback session and must be the parent/caregiver/guardian who received the feedback passport card and evaluation report. | Behavioural | Health Literacy |
| No Passport cardAfter receiving neurocognitive testing and verbal feedback from the psychologist, approximately 7 - 14 weeks after testing, caregivers will complete a brief questionnaire in person during their follow-up clinic visit or via phone if necessary. The person completing the parent/caregiver/guardian report must have been present for the evaluation and feedback session and must be the parent/caregiver/guardian who received the feedback and evaluation report, but not the passport card. | Behavioural | Standard of Care |
Primary outcome
Caregiver Understanding
Time frame: 7-14 weeks post evaluation
Evaluate differences in caregiver understanding of neurocognitive report findings when provided with a health-literate passport card compared to the control group through the semi-structured interview.
Caregiver Follow-through
Time frame: 7-14 weeks post evaluation
Evaluate differences in follow-through on neurocognitive report recommendations when provided with a health-literate passport card compared to the control group through the semi-structured interview.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Background: PubMed 28538513Acquazzino MA, Miller M, Myrvik M, Newby R, Scott JP. Attention Deficit Hyperactivity Disorder in Children With Sickle Cell Disease Referred for an Evaluation. J Pediatr Hematol Oncol. 2017 Jul;39(5):350-354. doi: 10.1097/MPH.0000000000000847.
- Background: PubMed 15952997Anie KA. Psychological complications in sickle cell disease. Br J Haematol. 2005 Jun;129(6):723-9. doi: 10.1111/j.1365-2141.2005.05500.x.
- Background: PubMed 29243544Baum KT, von Thomsen C, Elam M, Murphy C, Gerstle M, Austin CA, Beebe DW. Communication is key: the utility of a revised neuropsychological report format. Clin Neuropsychol. 2018 Apr;32(3):345-367. doi: 10.1080/13854046.2017.1413208. Epub 2017 Dec 15.
- Background: PubMed 17364569Berkelhammer LD, Williamson AL, Sanford SD, Dirksen CL, Sharp WG, Margulies AS, Prengler RA. Neurocognitive sequelae of pediatric sickle cell disease: a review of the literature. Child Neuropsychol. 2007 Mar;13(2):120-31. doi: 10.1080/09297040600800956.
- Background: PubMed 28221286Brandow AM, Zappia KJ, Stucky CL. Sickle cell disease: a natural model of acute and chronic pain. Pain. 2017 Apr;158 Suppl 1(Suppl 1):S79-S84. doi: 10.1097/j.pain.0000000000000824. No abstract available.
- Background: PubMed 29658377Caldwell EP, Carter P, Becker H, Mackert M. The Use of the Newest Vital Sign Health Literacy Instrument in Adolescents With Sickle Cell Disease. J Pediatr Oncol Nurs. 2018 Sep/Oct;35(5):361-367. doi: 10.1177/1043454218767875. Epub 2018 Apr 16.
- Background: PubMed 29178654Creary S, Adan I, Stanek J, O'Brien SH, Chisolm DJ, Jeffries T, Zajo K, Varga E. Sickle cell trait knowledge and health literacy in caregivers who receive in-person sickle cell trait education. Mol Genet Genomic Med. 2017 Nov;5(6):692-699. doi: 10.1002/mgg3.327. Epub 2017 Aug 23.
- BackgroundDaly, B. P., Kral, M. C., & Brown, R. T. (2008). Cognitive and academic problems associated with childhood cancers and sickle cell disease. School Psychology Quarterly, 23(2), 230-242. https://doi.org/10.1037/1045-3830.23.2.230
- Background: PubMed 24146229Davis DW, Jones VF, Logsdon MC, Ryan L, Wilkerson-McMahon M. Health promotion in pediatric primary care: importance of health literacy and communication practices. Clin Pediatr (Phila). 2013 Dec;52(12):1127-34. doi: 10.1177/0009922813506607. Epub 2013 Oct 21.
- Background: PubMed 12808013Gil KM, Carson JW, Porter LS, Ready J, Valrie C, Redding-Lallinger R, Daeschner C. Daily stress and mood and their association with pain, health-care use, and school activity in adolescents with sickle cell disease. J Pediatr Psychol. 2003 Jul-Aug;28(5):363-73. doi: 10.1093/jpepsy/jsg026.
- Background: PubMed 29659914Hardy SJ, Bills SE, Wise SM, Hardy KK. Cognitive Abilities Moderate the Effect of Disease Severity on Health-Related Quality of Life in Pediatric Sickle Cell Disease. J Pediatr Psychol. 2018 Sep 1;43(8):882-894. doi: 10.1093/jpepsy/jsy019.
- Background: PubMed 20195785Haywood C Jr, Lanzkron S, Ratanawongsa N, Bediako SM, Lattimer L, Powe NR, Beach MC. The association of provider communication with trust among adults with sickle cell disease. J Gen Intern Med. 2010 Jun;25(6):543-8. doi: 10.1007/s11606-009-1247-7. Epub 2010 Mar 3.
- Individual participant dataSharing planned: No. As of right now we are not going to share study documents or data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Karst, PhD principal investigator
Medical College of Wisconsin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passport Card and No Passport card in people with Sickle Cell Disease, run by Medical College of Wisconsin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Understanding (time frame: 7-14 weeks post evaluation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04917783, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.